    [House Hearing, 111 Congress]
    [From the U.S. Government Publishing Office]

                  ALZHEIMER'S DISEASE: THE ONGOING CHALLENGES

    =======================================================================

                                    HEARING

                                   BEFORE THE

                             SUBCOMMITTEE ON HEALTH

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                         ONE HUNDRED ELEVENTH CONGRESS

                                 SECOND SESSION

                                   __________

                                DECEMBER 9, 2010

                                   __________

                               Serial No. 111-162

          Printed for the use of the Committee on Energy and Commerce

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                        COMMITTEE ON ENERGY AND COMMERCE

                     HENRY A. WAXMAN, California, Chairman
    JOHN D. DINGELL, Michigan            JOE BARTON, Texas
      Chairman Emeritus                    Ranking Member
    EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
    RICK BOUCHER, Virginia               FRED UPTON, Michigan
    FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
    BART GORDON, Tennessee               NATHAN DEAL, Georgia
    BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
    ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
    BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
    ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
    GENE GREEN, Texas                    STEVE BUYER, Indiana
    DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
      Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
    LOIS CAPPS, California               MARY BONO MACK, California
    MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
    JANE HARMAN, California              LEE TERRY, Nebraska
    TOM ALLEN, Maine                     MIKE ROGERS, Michigan
    JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
    CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
    JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
    TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
    MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
    ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
    JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
    G.K. BUTTERFIELD, North Carolina
    CHARLIE MELANCON, Louisiana
    JOHN BARROW, Georgia
    BARON P. HILL, Indiana
    DORIS O. MATSUI, California
    DONNA M. CHRISTENSEN, Virgin
        Islands
    KATHY CASTOR, Florida
    JOHN P. SARBANES, Maryland
    CHRISTOPHER S. MURPHY, Connecticut
    ZACHARY T. SPACE, Ohio
    JERRY McNERNEY, California
    BETTY SUTTON, Ohio
    BRUCE L. BRALEY, Iowa
    PETER WELCH, Vermont
                             Subcommittee on Health

                    FRANK PALLONE, Jr., New Jersey, Chairman
    JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
    BART GORDON, Tennessee                   Ranking Member
    ANNA G. ESHOO, California            RALPH M. HALL, Texas
    ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
    GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
    DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
    LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
    JANICE D. SCHAKOWSKY, Illinois       MARY BONO MACK, California
    TAMMY BALDWIN, Wisconsin             MIKE FERGUSON, New Jersey
    MIKE ROSS, Arkansas                  MIKE ROGERS, Michigan
    ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
    JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
    JANE HARMAN, California              TIM MURPHY, Pennsylvania
    CHARLES A. GONZALEZ, Texas           MICHAEL C. BURGESS, Texas
    JOHN BARROW, Georgia
    DONNA M. CHRISTENSEN, Virgin
        Islands
    KATHY CASTOR, Florida
    JOHN P. SARBANES, Maryland
    CHRISTOPHER S. MURPHY, Connecticut
    ZACHARY T. SPACE, Ohio
    BETTY SUTTON, Ohio
    BRUCE L. BRALEY, Iowa

                                 C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Frank Pallone, Jr., a Representative in Congress from the
      State of New Jersey, opening statement.........................     1
    Hon. Phil Gingrey, a Representative in Congress from the State of
      Georgia, opening statement.....................................     3
    Hon. Lois Capps, a Representative in Congress from the State of
      California, opening statement..................................     4
    Hon. John Barrow, a Representative in Congress from the State of
      Georgia, opening statement.....................................     5
    Hon. Donna M. Christensen, a Representative in Congress from the
      Virgin Islands, opening statement..............................     6
    Hon. Zachary T. Space, a Representative in Congress from the
      State of Ohio, opening statement...............................     7
    Hon. Anna G. Eshoo, a Representative in Congress from the State
      of California, prepared statement..............................    57
    Hon. Joe Barton, a Representative in Congress from the State of
      Texas, prepared statement......................................    59
    Hon. Joseph R. Pitts, a Representative in Congress from the
      Commonwealth of Pennsylvania, prepared statement...............    63
    Hon. Marsha Blackburn, a Representative in Congress from the
      State of Tennessee, prepared statement.........................    65

                                   Witnesses

    Marcelle Morrison-Bogorad, Director, Division of Neuroscience,
      National Institute on Aging, National Institutes of Health.....     9
        Prepared statement...........................................    12
    Harry Johns, President and Chief Executive Officer, Alzheimer's
      Association....................................................    22
        Prepared statement...........................................    25
    Eric J. Hall, President and Chief Executive Officer, Alzheimer's
      Foundation of America..........................................    31
        Prepared statement...........................................    33
    Marc Cantillon, M.D., Executive Director, Coalition Against Major
      Disease, Critical Path Institute...............................    39
        Prepared statement...........................................    41

                               Submitted Material

    Article entitled, ``Evidence for Neurocognitive Plasticity in At-
      Risk Older Adults: The Experience Corps Program,'' in Journal
      of Gerontology: Medical Sciences, 2009, submitted by Mr.
      Shimkus........................................................    68

                  ALZHEIMER'S DISEASE: THE ONGOING CHALLENGES

                                  ----------

                           THURSDAY, DECEMBER 9, 2010

                      House of Representatives,
                                Subcommittee on Health,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 1:47 p.m., in
    Room 2322, Rayburn House Office Building, Hon. Frank Pallone,
    Jr., [chairman of the subcommittee] presiding.
        Present: Representatives Pallone, Engel, Capps, Barrow,
    Christensen, Space, Gingrey, and Markey.
        Staff Present: Ruth Katz, Chief Public Health Counsel;
    Sarah Despres, Counsel; Steve Cha, Professional Staff Member;
    Allison Corr, Special Assistant; Alvin Banks, Special
    Assistant; Elizabeth Letter, Special Assistant; Ronald Allen,
    Staff Assistant; Clay Alspach, Minority Counsel, Health; Sean
    Hayes, Minority Counsel, Oversight and Investigations; and Ryan
    Long, Minority Chief Counsel, Health.

    OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
                IN CONGRESS FROM THE STATE OF NEW JERSEY

        Mr. Pallone. The meeting of the House subcommittee is
    called to order. And today we have a hearing on Alzheimer's
    disease and its ongoing challenges, and I will recognize myself
    for an opening statement.
        As many of us know, Alzheimer's disease is an irreversible
    progressive brain disease that slowly destroys memory and
    thinking skills and, eventually, even the ability to carry out
    the simplest task. Damage first strikes the areas of the brain
    that control memory, and problems in memory are the first
    symptoms to be noticed in early stages of Alzheimer's disease.
    As deterioration progresses to other areas of the brain,
    problems with other brain functions develop as well, as severe
    Alzheimer's disease can affect every part of the brain and rob
    its victims of their very lives and dignity.
        Alzheimer's disease is fatal. It is estimated to be the
    sixth leading cause of death in our country. NIH estimates that
    as many as 5.1 million Americans may have Alzheimer's today,
    and this figure is expected to grow to 13.5 million Americans
    by 2050.
        The truth of the matter, though, is that these figures give
    an incomplete snapshot of Alzheimer's disease and related
    dementias. Alzheimer's disease is, at the heart, a family
    disease, as the intense caretaking that those afflicted with
    the disease requires places a heavy financial and emotional
    burden on the family. The serious medical complications related
    to Alzheimer's disease mean that caregivers often struggle to
    maintain work outside their home to earn a living, while
    balancing a never-ending schedule of monitoring and treatment
    for family members living with the disease.
        For many adults, known as the sandwich generation, they are
    duly responsible for caring for their aging parents while they
    are also caring for their children. And Alzheimer's has a
    devastating impact not just on families but on our national
    economy. It is projected that the national cost associated with
    caring for those with Alzheimer's exceeds $172 billion each
    year, with the figure expected to rise to $1 trillion by 2005.
    And these costs represent the burden on Medicare, Medicaid,
    private insurance caregiving and out-of-pocket costs for
    families. Of this figure, $123 billion can be attributed to
    Medicare and Medicaid alone.
        Until we cure Alzheimer's, it is imperative that our health
    care system provides stronger support for families caring for
    loved ones with the disease. The Affordable Care Act, which we
    passed earlier this year, establishes the Community Living
    Assistance Services and Support, or CLASS programs, a new
    national long-term care insurance option. This legislation also
    provides Medicare beneficiaries with free annual wellness
    visits, which may increase the detection of early cognitive
    impairment, enabling patients and families to better plan for
    care needs. And, finally, the Affordable Care Act will ensure
    that Americans living with Alzheimer's disease and other
    preexisting conditions will not have to worry about having
    their insurance coverage discontinued or denied.
        In the future, whether families are subject to the triumph
    or tragedy of Alzheimer's will be dependent on the innovation
    and new drugs and therapies being investigated in laboratories
    across our Nation. And today we are going to hear from the
    National Institute on Aging at the NIH about the great work
    their scientists are doing to better understand, diagnose, and
    treat Alzheimer's disease. NIA's translation objectives have
    focused on supporting early drug discovery and preclinical drug
    development of novel compounds for Alzheimer's therapy.
        We are also going to hear from the Coalition Against Major
    Diseases within the Critical Path Institute on its efforts to
    improve applied regulatory science and how this will strengthen
    our ability to treat diseases like Alzheimer's.
        And, finally, we will hear from the Alzheimer's Association
    and Alzheimer's Foundation of America about the key research
    they are supporting, as well as their initiatives and resources
    that help support day-to-day caretaking of individuals with
    Alzheimer's.
        Now, many of the members of this committee have been
    touched by Alzheimer's and expressed interest in examining the
    complex issues related to the disease. I do want to highlight
    the exemplary leadership and advocacy for Alzheimer's disease
    by a member of our full committee, Mr. Markey. I think he is
    going to be able to come today, but he basically has been
    touched, of course, by his late mother's own struggle with the
    disease, and because of that and for a lot of reasons he has
    been an energetic leader in Congress and also chairs the
    Congressional Caucus on Alzheimer's disease. So he may be
    joining us later, but I did want to mention him today.
        And I will now recognize for an opening statement our
    ranking member, Mr. Gingrey.

      OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF GEORGIA

        Mr. Gingrey. Mr. Chairman, thank you. And I certainly want
    to thank our witnesses for their patience with us today. The
    witnesses will testify, as we hear from them, Alzheimer's
    disease presents a looming threat to the health of our Nation,
    and today I think the number is as many as 5 million Americans
    in the United States have this dreaded disease. And the
    scientific community is in agreement that these numbers will
    only increase significantly in the coming years as our society
    ages.
        According to the United States Census Bureau, the number of
    seniors age 65 and older will actually double to about 72
    million in the next 20 years as these baby boomers all reach
    retirement age. However, as Dr. Morrison-Bogorad will testify,
    the generation behind them, I think this is what is referred to
    as Generation X, and these are the folks born between 1965 and
    1980, it is a significantly smaller generation than the baby
    boomers.
        So why is this comparison significant for the purposes of
    the hearing today? As Alzheimer's is a degenerative and, as of
    yet, incurable disease that requires constant monitoring, the
    role of the main caregiver often falls to our family members,
    as we all know. According to a study conducted by the
    Alzheimer's Association, an estimated 11 million Americans
    provide 12.5 billion hours of unpaid care annually for people,
    usually their loved ones, with Alzheimer's and other dementias.
        The disease also does require large amounts of medical care
    in addition to in-home and community-based services. This high
    use of medical services results in substantial cost to the
    Federal Government, States, employers, and indeed families.
        If the number of Alzheimer's patients does indeed double
    over the next 20 years as many predict it will, we could be
    facing a health care crisis if the number of family caregivers
    declines, and of course the costly care for these patients
    ultimately shifts to paid health care professionals.
        Alzheimer's disease is also a personal issue for me. My
    wife's mother, Laura Neill Ayers, was a very healthy and
    vibrant 88-year-old woman. She didn't hear very well. I think
    she loved that. But she was active. She loved to watch sports,
    and she spent time in her room every day watching baseball. Her
    husband, Bill Ayers, actually played baseball for the New York
    Giants in the 1940s, and Laura picked up her love of the game
    from her husband. Watching baseball became one of her favorite
    pastimes and thoughts of spring training I think kept her warm
    all winter long.
        Seemingly overnight, all of that changed. She was diagnosed
    with dementia and, we suspect, Alzheimer's halfway through her
    89th year, and the woman that we know and love was changed
    forever. Gone was the active woman, 88. In her place was a
    woman that seemingly was trapped inside her own body, unable to
    enjoy the comforts of these golden years.
        I cannot begin to describe how emotionally destructive this
    disease was, as many of you I am sure know, not only for my
    mother-in-law but for my entire family.
        There are many stories like this one that help underscore
    the importance of finding a cure. Today there are no known
    treatments to prevent, cure, or even delay the onset of
    Alzheimer's. The five drugs currently approved by the FDA have
    been shown to be successful in reducing the symptoms of the
    disease, but much more needs to be done to ultimately find a
    cure.
        And so with that thought in mind, I would like to welcome
    all of our witnesses here today. Specifically, I am interested
    in hearing from Dr. Marc Cantillon, the executive director of
    the Coalition Against Major Diseases for the Critical Path
    Institute. As Dr. Cantillon will touch on in his testimony, the
    goal of his organization is to promote a forum for scientists
    from the FDA, academia, and industry to evaluate innovative
    testing methods for the use in drug development.
        As members of this subcommittee have heard during past
    hearings, pharmaceutical drug development in the United States
    can benefit from greater collaboration between industry and the
    FDA. To the FDA's credit, they have recognized this fact in
    many areas, including antibiotic drug development, something
    for which I and a bipartisan group of members on this
    subcommittee will be advancing pieces of legislation in the
    112th Congress.
        As a representative of the citizens of the 111th of
    Georgia, I believe the government works best when its processes
    are constantly scrutinized and reformed, when necessary, to
    ensure they work as efficiently as possible. That theory
    applies not only to Congress and the White House, but
    government agencies as well. Therefore, I hope to learn more
    about this phrase, ``applied regulatory science,'' during the
    question-and-answer portion of the hearing and how it might
    improve patient access to quality care.
        Mr. Chairman, thank you for scheduling this hearing today.
    And with that, I see my time has expired and I yield back.
        Mr. Pallone. Thank you, Mr. Gingrey.
        Mr. Gingrey. Mr. Chairman, I did want to ask for unanimous
    consent to submit for the record our actual subcommittee
    ranking member, Mr. Shimkus, a study that comes out of John
    Hopkins, ``Evidence for Neurocognitive Plasticity in At-Risk
    Older Adults,'' and the experience of that study.
        Mr. Pallone. Without objection, so ordered.
        [The information appears at the conclusion of the hearing.]
        Mr. Pallone. Next for an opening statement, the gentlewoman
    from California, our vice chair, Mrs. Capps.

       OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
                 CONGRESS FROM THE STATE OF CALIFORNIA

        Mrs. Capps. Thank you, Chairman Pallone, for holding this,
    the final Health Subcommittee of the 111th Congress. And I want
    to thank you for your wonderful service as chairman over the
    last 4 years.
        Alzheimer's disease is a very topical subject for this
    hearing, because the challenges faced by patients and their
    loved ones are so reflective of the challenges we face
    throughout our health care system. Long term, these are some of
    the challenges which fit with Alzheimer's so well: long-term
    care availability and its costs; respite care; an adequate
    workforce; and research for better treatments and a cure.
        Now, that is just touching the surface of the many
    challenges that we face with this and so many other chronic
    conditions. And thankfully, the new health care law provides
    much-needed relief for many of these concerns. One of these is
    the new long-term care insurance option. There is also Medicare
    prescription cost relief. And there is opportunities for
    training the next generation of health professionals; in
    addition, the Cures Acceleration Network, along with what our
    chairman mentioned as the CLASS Act. And, of course, we have a
    lot more that we should undertake now within this framework of
    the new legislation.
        Some of these other steps we can take, such as passage of
    legislation that I am very proud to cosponsor in the National
    Alzheimer's Act I know you are going to be addressing today in
    your testimony, including the National Alzheimer's project,
    with the goal being that we can provide and develop a
    comprehensive strategy for how to address Alzheimer's disease,
    how to continue, as many of you have been doing over these past
    many years.
        So I do look forward to hearing from our witnesses today
    about the latest in Alzheimer's research. I understand there
    are some very critical breakthroughs that have been working
    their way through the clinical trials and so forth, and also
    what you see for us in guidance in the next Congress as
    pressing needs that patients and so many of them, increasing
    numbers of their family members and caregivers, are going to
    experience.
        As has also been mentioned, there is probably not one
    person in this room who hasn't been touched personally by this
    devastating disease. And we need to know it is a crisis
    proportion, really, in our society now, how to best equip
    ourselves and our communities to cope with it.
        So I yield back and look forward to today's hearing.
        Mr. Pallone. Thank you. And I also wanted to thank you also
    as the vice chair. You have been really tremendously helpful,
    and so often giving us insight on issues because of your
    practical experience also as a nurse and your background. So
    thank you.
        Our next member for an opening statement, the gentleman
    from Georgia, Mr. Barrow.

      OPENING STATEMENT OF HON. JOHN BARROW, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF GEORGIA

        Mr. Barrow. Thank you, Mr. Chairman. I want to thank you
    also for your leadership throughout the 111th Congress on this
    committee.
        The poet said that comparisons are odious, and at the
    personal level no one wants their personal trauma or tragedy
    compared to someone else's. But at the level of public health
    and social impact, I think some comparisons are useful. The
    scourge of cancer has many faces. The scourge of Alzheimer's
    has a very definite profile, many different impacts on folks,
    but a very different impact in terms of the family.
        I think it is useful to point out that we didn't really
    begin to marshal the Nation's resources in the war on cancer
    until folks could say, everybody knows somebody who has been
    touched by cancer. I think it is fair to say that everybody now
    knows somebody who has been touched by Alzheimer's. Nobody
    knows the particular impact it has on family and on the
    communities of interest around families that is the hallmark of
    this dreaded disease. So I think we can take inspiration from
    the fact that so many folks are impacted by this.
        I think it is important to point out also in ways that
    supplement what others have said, the cost of this disease. The
    uncompensated care and the out-of-pocket expense to our system
    is staggering and growing exponentially in ways that I think
    compare very unfavorably to some of the other diseases that we
    deal with at a social level. Right now, we are spending
    something like $170-plus billion a year in compensated and
    uncompensated care, taking into account the fair market value
    of the services that folks are being forced to render and not
    getting any kind of compensation for at all. That is coming out
    of our gross social product. It is projected to cost our
    society something on the order of $1 trillion a year at current
    growth levels by the time we reach 2050. So it is staggering in
    its potential for exponential growth and impact on folks.
        The point is, this is not only the right thing to do in
    terms of the quality of the life of folks affected by this. It
    has never been truer to say that this is not only the right
    thing to do, but it is the smart thing for us to do, to marshal
    our resources in more effectively and economically managing and
    treating and preventing this dreaded disease.
        So, with that, I look forward to hearing the testimony of
    our witnesses and thank them for coming today. And I thank you,
    Mr. Chairman, for making this, the last hearing of this
    committee and this Congress, a very large issue that we are
    going to be dealing with for a very long time.
        With that, I yield back.
        Mr. Pallone. Thank you, Mr. Barrow.
        Next, the gentlewoman from the Virgin Islands, Mrs.
    Christensen.

           OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
           REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

        Mrs. Christensen. Here thank you, Mr. Chairman. And thank
    you for holding this hearing. And thank you, welcome to the
    folks who are here to testify. And thank you not only for
    taking the time to be here but for the work that you all are
    doing. I really appreciate the approach that is being taken to
    this devastating disease, a disease that is devastating to not
    only individuals but families and communities, and potentially
    to our country, because it is a wholistic approach, looking at
    prevention, treatment, and research, but also looking at the
    caregivers who are often forgotten.
        I wanted to call attention to several areas.
        First, the cost of care. Due to the cost of care, this
    disease has the potential to bankrupt our health care system
    unless we invest in all of these aspects today. In fact, by
    2050, it is estimated that 13.5 million Americans will be
    suffering from Alzheimer's, and the cost might be as much as $1
    trillion a year.
        Second, there is a grave discrepancy between the funding
    for research for this sixth leading cause of death compared to
    other leading causes of death, where billions are being spent
    compared to just over $400 million on Alzheimer's.
        Third, I want to call attention to the fact that racial and
    ethnic minorities are disproportionately impacted with
    Alzheimer's, with African Americans being twice more likely and
    Hispanic Americans 1.5 more likely to suffer from Alzheimer's
    and other dementias, despite the fact that they are
    underdiagnosed compared to their white counterparts.
        And I wanted to mention, too, other pieces of legislation
    just to show that the Congressional Black Caucus has been aware
    and engaged in this issue for several years. One is H.R. 4123,
    the Alzheimer's Treatment and Caregivers Support Act,
    introduced by Representative Maxine Waters, and H.R. 1192, the
    Alzheimer's Family Assistance Act, introduced by Eddie Bernice
    Johnson. Both of these bills, like the others that are being
    mentioned in the testimonies, will help to take the fight
    against Alzheimer's several steps forward and be a part of this
    solution to this devastating problem.
        So, again, thank you, Mr. Chairman. And thanks, all of you,
    for being here.
        Mr. Pallone. I thank the gentlewoman.
        And next is the gentleman from Ohio, Mr. Space.

    OPENING STATEMENT OF HON. ZACHARY T. SPACE, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF OHIO

        Mr. Space. Thank you, Mr. Chairman. Today is my final
    hearing in committee, and I wanted to first express my
    gratitude to Mr. Chairman and to Chairman Waxman, as well as
    members on both sides of the aisle, for their work in some of
    the most profound issues of the day and even a generation:
    issues like energy and health care and the transformational
    effect that the whole broadband era has brought to this country
    and to our culture. And while we didn't accomplish everything
    that I think we had set out to accomplish, we got a lot done.
    And there is a lot to be done.
        My district back in Ohio is a very rural district. It is
    Appalachian Ohio, where the people are good and they work hard,
    a lot of good things going for us back there. But there are a
    lot of challenges that we have, and we share those challenges
    with the rest of rural America. And one of the things that is
    unique about this committee, I think, is the effect that it can
    have on bridging the divide that exists between urban and
    suburban America and rural America. And certainly the divide
    does exist when it comes to accessing education, certainly with
    regards to accessing health care. And I encourage the committee
    to be every bit as ambitious in tackling some of those
    challenges in the upcoming session of Congress.
        With respect to the issue of today, Alzheimer's, I
    sympathize with the remarks of my colleague and friend from
    Georgia, Mr. Barrow; $172 billion a year, those are war-like
    numbers. In other words, those are the kind of numbers you
    spend when you go to war. If you couple the amount of money
    that we are spending as a society on a disease like Alzheimer's
    with what we are spending on diseases like diabetes, cancer,
    and the list goes on and on, it soon reaches the trillion-
    dollar level. In fact, Alzheimer's alone, by the year 2050,
    will reach that level. And we cannot sustain that as an
    economy.
        When John Barrow says it is not only the humane thing to
    do, it is the right thing to do, what he is saying is if it is
    not important enough to deal with these issues simply because
    of the mitigation of human suffering that occurs as a result of
    these diseases, then certainly we should be able to justify it
    because of the cost. And like Alzheimer's and diabetes and
    cancer, the answer, at least from the congressional
    perspective, is in medical research. We cannot simply rely upon
    the private sector to tackle these diseases, not simply because
    it is not the right thing to do but we can't afford it.
        For every dime we invest today in research, we will receive
    a return of dollars in the future. Many dollars. So I urge this
    committee in future efforts, including its efforts with regards
    to Alzheimer's, to bear in mind the obligation that we have as
    an institution, as a government, and the duty we have to our
    people to conquer these diseases through early diagnosis,
    advanced diagnosis, advanced treatment, and above all, cure.
    Let's not forget cure.
        With that, Mr. Chairman, again thank you for your
    leadership, and it has been a pleasure serving on your
    committee.
        Mr. Gingrey. Mr. Chairman, could I have a brief point of
    personal privilege, a friendly point of personal privilege?
        Mr. Pallone. Absolutely.
        Mr. Gingrey. And let me first of all, to my friend from
    Ohio, Mr. Space--and he truly is my friend and he and I know
    that--indeed we will miss him. He is a great member with a
    great heart, and I think the words that he just expressed to
    this committee indicate the type of person that he is. And,
    Zack, we will miss you and I really enjoyed serving with you.
    And I hope we will keep in touch, my friend.
        Also, I wanted to say to you, Mr. Chairman, and I say this
    on behalf of my colleagues who I guess are on airplanes about
    now, trying to get home to their families, and not the least of
    which, of course, would be ranking member John Shimkus. We have
    really enjoyed serving with you, under you, on this Health
    Subcommittee of Energy and Commerce, not always agreeing on
    every vote, in fact disagreeing a lot of times. But no one
    could be more agreeable when he disagrees. Mr. Chairman, We
    respect you and hold you in high regard and look forward to
    serving with you in the 112th.
        Mr. Pallone. Well, thank you. I really appreciate that. And
    I want to say the same about you. Your input not only as a
    physician, but just in general, has been fantastic. And I kind
    of wish that Mr. Shimkus was here today, too, because I wanted
    to say how easy it was to work with him in the last--I guess
    not 2 years, a little over a year or so. And it is true, I
    think, that even though we often disagree on a lot of issues,
    that we have been able to work together on many issues. And it
    kind of bothers me sometimes when the media, I guess, pays
    attention to the differences and doesn't highlight how many
    bills we have actually passed out and worked on together and
    got signed into law that were very important for the American
    people. So thank you.
        And let me say about Mr. Space. Again, I know that I am
    really going to miss him. He has really contributed a lot and
    he has been a friend on so many issues. So thank you. Thank you
    very much.
        So we will get to our panel. Let me welcome you, first of
    all. We only have one panel today, so I will introduce the
    members.
        Starting on my left is Dr. Marcelle Morrison-Bogorad, who
    is director of the Division of Neuroscience at the National
    Institute on Aging, with the National Institutes of Health.
        And next is Mr. Harry Johns, who is president and chief
    executive officer of the Alzheimer's Association.
        And then we have Mr. Eric J. Hall, who is president and
    chief executive officer of the Alzheimer's Foundation of
    America.
        And, finally, Dr. Marc Cantillon, who is executive director
    of the Coalition Against Major Disease, from the Critical Path
    Institute, and also happens to be a constituent, so I should
    know how to pronounce his name, from one of my towns,
    Kingsbury. So thank you in particular for being here today.
        We have 5-minute opening statements that become part of the
    record, and each of you can also submit additional statements
    in writing for inclusion if you would like.

    STATEMENTS OF MARCELLE MORRISON-BOGORAD, DIRECTOR, DIVISION OF
    NEUROSCIENCE, NATIONAL INSTITUTE ON AGING, NATIONAL INSTITUTES
    OF HEALTH; HARRY JOHNS, PRESIDENT AND CHIEF EXECUTIVE OFFICER,
      ALZHEIMER'S ASSOCIATION; ERIC J. HALL, PRESIDENT AND CHIEF
    EXECUTIVE OFFICER, ALZHEIMER'S FOUNDATION OF AMERICA; AND MARC
     CANTILLON, M.D., EXECUTIVE DIRECTOR, COALITION AGAINST MAJOR
                    DISEASE, CRITICAL PATH INSTITUTE

        Mr. Pallone. And I will now recognize Dr. Morrison-Bogorad.

                 STATEMENT OF MARCELLE MORRISON-BOGORAD

        Ms. Morrison-Bogorad. Thank you very much, Chairman. And I
    really thank you for inviting me to appear before you today to
    discuss the pressing issue of Alzheimer's disease.
        The National Institute on Aging is the lead institute for
    Alzheimer's disease of the NIH. So in this regard I want to
    tell you that you can now download copies of our 2009
    congressionally mandated ``NIH Progress Report on Alzheimer's
    Research'' from the NIH Web site.
        I am retiring at the end of this year and am truly sad that
    a cure for Alzheimer's has not been found on my watch. But the
    momentum is there, and I believe that my successor will have
    this joy.
        Federal researchers, other scientific agencies, the private
    sector, and not-for-profit are collaborating as never before to
    try to solve the mysteries of this disease. For example, we
    have regular meetings with each of the entities that will
    testify at this hearing. We have partnered with the Alzheimer's
    Association on many occasions, and ongoing is a joint venture
    on updating the definition of AD.
        The Alzheimer's Foundation of America and other
    organizations held House and Senate briefings a couple of weeks
    ago where Richard Hodes, director of NIA, was asked to testify.
    And we work with the Coalition Against Major Diseases for the
    Critical Path Institute on matters related to innovations and
    marker use on clinical trials.
        The NIA plans and manages an extensive program to better
    treat and ultimately to prevent Alzheimer's. How do we do this?
    Well, from our Alzheimer's Summit in 2006, the 2010 State of
    the Science Conference, from numerous specialized workshops,
    from program review by our NIA Council every 4 years, we get
    input from all these sources, and from these decide on the best
    ways to advance Alzheimer's research commensurate with our
    funding.
        For example, at the 2006 Summit, it was recommended that we
    develop a project focusing on early onset AD families. We have
    since funded the International Dominantly Inherited Alzheimer's
    Network to study preclinical disease in these families. Earlier
    this year, an NIH State of the Science Conference reported that
    there was, so far, insufficient evidence that any behavioral
    interventions for AD or age-related cognitive decline were
    effective, and that we ought to devote more resources to these
    questions.
        Even before the report was finalized, we had stepped up our
    funding of clinical trials to get definitive evidence whether
    or not various exercise and cognitive interventions might
    impact age-related cognitive decline, mild cognitive
    impairment, and AD. Now we are funding around 20 such trials.
        The Alzheimer's Disease Neuroimaging Initiative is another
    example of our leadership. ADNI is a very successful public-
    private partnership to identify biological and imaging markers
    for better ways of monitoring AD clinical trials and also
    identifying persons at risk for the disease preclinically. Here
    we initiated the process through a series of meetings where we
    brought together all interested parties to discuss what
    initiative would be most useful for them for development in a
    precompetitive setting, and these discussions led to funding of
    ADNI in 2004, with substantial financial support from industry
    and from not-for-profits such as the Alzheimer's Association,
    coordinated by the Foundation for NIH.
        Another aspect of our planning process is to ask our
    director for funds to specifically target new areas that need
    to be developed. An example is our Translational Initiative.
    Partly through these targeted funds, this important and
    innovative portfolio has grown to over 60 projects, each aimed
    squarely at bringing a new drug to the stage where it can get
    FDA approval for performing clinical trials. This is a
    particularly important area for us to develop, as
    pharmaceutical companies are often unwilling to put monies into
    the beginnings of the drug discovery process and translational
    research.
        One reason that drug trials have not worked so far may be
    that the drugs are given too late in the disease to have any
    effect, but prevention trials to test those possibilities take
    a lot of money and time under current protocols. We are
    developing new methodologies, and in the meantime we have been
    able to fund a number of prevention trials by the simple way of
    adding cognitive measures on to trials started for other
    clinical conditions often by other institutes. So it is a cheap
    way of funding these trials.
        But other possible drug therapies for Alzheimer's are
    directed against unique aspects of the disease, and so for
    these more specialized interventions NNIA must continue to
    develop AD-specific trials.
        We make difficult decisions all the time about where to put
    our resources. We do not have a crystal ball to tell us what
    approach will eventually pay off in relieving suffering from
    this frightening disease. We are committed to trying every
    promising avenue, and we will succeed. Thank you.
        Mr. Pallone. Thank you very much.
        [The prepared statement of Ms. Morrison-Bogorad follows:]

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        Mr. Pallone. Next is Mr. Harry Johns.

                        STATEMENT OF HARRY JOHNS

        Mr. Johns. Thank you very much, Chairman Pallone,
    distinguished members of the committee. I want to also thank
    Ranking Member Shimkus and all of you for holding this hearing
    this afternoon.
        My name is Harry Johns. I am the president and CEO of the
    Alzheimer's Association. The Alzheimer's Association was
    created in 1980 and is the leading voluntary health
    organization in both the provision of Alzheimer's care and
    support, and in the funding of Alzheimer's research, as the
    largest nonprofit funder of Alzheimer's research in the world.
        To do our job well, we spend a lot of time listening,
    listening to people with Alzheimer's, their caregivers, their
    families, to researchers, our many collaborators, and to
    hundreds of thousands of our advocates. We hear their stories
    and experiences, and they inspire us to go further, faster, to
    provide better care, and ultimately the cure that we all seek.
    We listen to those families in your districts and we listen to
    our own families.
        My mother had Alzheimer's disease herself. Any of us who
    have seen the disease up close don't want to see it again, for
    anyone to have the disease or to be a caregiver. Regrettably,
    we know it is going to happen much more ahead of us.
        You know, the effects of Alzheimer's, as it has been stated
    previously, are truly devastating at the human level. In this
    country alone, as previously referenced, we estimate actually
    there are about 5.3 people who have the disease, about 200,000
    of them younger onset, younger than 65. And by the middle of
    the century it could be as high as 13.5, or even as high as 16
    million individuals in the United States alone. Today, there
    are 35 million people worldwide who have the disease.
        Today, if you do develop Alzheimer's, we can say with
    certainty, absolute certainty, that you will either die with
    the disease or of it. And of the 10 leading causes of death, as
    previously mentioned, Alzheimer's is now sixth, Alzheimer's is
    growing by far the most rapidly, a 50 percent increase between
    2000 and 2007, the last year that statistics are available. And
    it is the only one of the top 10 causes of death that has
    nothing to do to prevent, stop, or even slow it. For
    perspective, even though Alzheimer's is likely seriously
    underreported, already today it is killing more people than
    diabetes and more people than breast cancer and prostate cancer
    combined.
        The 11 million caregivers in the United States, Alzheimer's
    can literally take everything they have to give: their time,
    their money, their jobs, and their own good health. And it
    happens every day, oftentimes never to be recovered. One study
    at least indicates that people who are caring for a spouse with
    Alzheimer's can actually predecease the individual with the
    disease.
        The economic impact of Alzheimer's is also devastating,
    truly staggering numbers. You have already mentioned the $172
    billion in costs today for Alzheimer's going as high as $1
    trillion by the middle of the century, which was reported in
    the Alzheimer's Association's trajectory report earlier this
    year. And those are in today's dollars. Those are not inflated
    dollars. Those are dollars rated in today's terms. A total of
    $20 trillion over the next 40 years just to pay for the care
    costs, not an additional cent for the research we so badly
    need. And our country is simply not ready for this onslaught of
    Alzheimer's that is already upon us.
        Let's take the case of research funding. You know, we have
    made significant progress in other diseases, in fact, in no
    small part because of the significant investments we have made
    in those diseases. Research spending at the Federal level for
    cancer is about $6 billion today; for a cardiovascular disease
    about $4 billion; for HIV/AIDS it is about $3 billion. Now, all
    of those are good investments. They have paid off in lives
    saved, and they are going to continue to pay in that way for
    our country. But in Alzheimer's, we are only spending $469
    million a year, despite those other huge impacts we have
    already discussed.
        We know that more money invested in research save lives,
    but we also know that too little money invested in research
    actually costs lives and ultimately will drive those very huge
    care costs into the trillions. Today, right now, we spend $250
    in America on care cost for Alzheimer's and dementia compared
    to $1 invested in research; 250 to 1.
        So to address the underinvestment in Alzheimer's research,
    the Alzheimer's Association strongly supports the Breakthrough
    Act. It is a bill that authorizes $2 billion in Alzheimer's
    research.
        But the Alzheimer's Association will not ask others to do
    what we won't do ourselves. We play an unparalleled role in the
    research community in Alzheimer's, globally as well as in the
    United States, and that certainly includes direct investment in
    Alzheimer's and effectively investing in science.
        Our peer-reviewed research program since its inception has
    funded $279 million worth of research to 1,900 investigators,
    making us the largest funder in the nonprofit world. And
    through partnerships and our own funding, we have played some
    kind of a part in every major advance over the past 30 years as
    a result.
        But as I discuss these necessary investments in Alzheimer's
    research, and more broadly, I certainly recognize that our
    country is currently engaged in a very appropriate and very
    necessary conversation about our fiscal situation, our fiscal
    situation as a country, and we have to address that. But
    Alzheimer's, unaddressed, is one of our most devastating
    issues, both human and financial, as we have all discussed. So
    we must aim at what is the highest return potential we have for
    investments, Alzheimer's one of them.
        So if we can't fix Alzheimer's, I don't think we can fix
    Medicare. Medicare costs three times more for each individual
    in the system who has Alzheimer's than it does for a normal
    individual.
        Mr. Pallone. Mr. Johns, I have been trying not to cut
    anybody off because we only have the one panel.
        Mr. Johns. Let me wrap really quickly then, Mr. Chairman.
        Certainly I want to mention the National Alzheimer's
    Project Act, and I want to thank this committee for its
    leadership. I certainly again want to recognize Congressman
    Markey who you mentioned for his leadership as the author;
    certainly recognize Dr. Burgess who has also provided
    leadership on this. And we know, of course, the Senate passed
    the bill yesterday. We look forward to the real possibility of
    the House passing it. We urge you to pass it. And we look
    forward to working with this committee and the Congress to
    realize the ambition of the Alzheimer's Association, its
    vision, a world without Alzheimer's disease.
        Mr. Pallone. Thank you.
        [The prepared statement of Mr. Johns follows:]

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        Mr. Pallone. Mr. Hall.

                       STATEMENT OF ERIC J. HALL

        Mr. Hall. Chairman Pallone, members of the committee, thank
    you so much for convening this hearing and for inviting the
    Alzheimer's Foundation of America to testify. I am Eric J.
    Hall. I am the AFA's founding president and chief executive
    officer, and I am truly honored to be here to testify on behalf
    of our member organizations and families that we care for
    across the country.
        AFA was formed in February of 2002 to provide optimal care
    and services to individuals confronting dementia, and to their
    caregivers and families, through member organizations dedicated
    to improving quality of life. Today our membership consists of
    more than 1,400 organizations, including grassroots not-for-
    profit organizations, government agencies, public safety
    departments, and long-term care communities.
        Our services include a toll-free hotline staffed by
    licensed social workers, educational materials; Care Advantage,
    which is a free quarterly family caregiver magazine that right
    now reaches about 1 million readers; professional training
    programs; AFA Teens, which is a Web-based support and
    scholarship program; and our National Memory Screening Date. As
    a foundation, our money is generated and disbursed by grants to
    service organizations as well as respite grants to families who
    are in need.
        Recognizing the severe fiscal challenges facing our Nation,
    it is more important than ever to leverage available private-
    sector resources in a cost-effective manner to support public-
    sector initiatives. AFA makes substantial investments in care
    and services to tackle the enormous challenges associated with
    Alzheimer's disease and related dementias for both individuals
    and their family caregivers.
        But the needs of the population are going to overwhelm our
    resources in the years to come. The National Institute on Aging
    reports that as many as 5.1 million Americans over 65 are,
    today, dying of Alzheimer's disease, and those numbers are
    projected to increase dramatically in the coming years. The
    rapidly rising costs associated with this disease will put an
    enormously heavy burden on families, businesses, and government
    economically.
        It is our opinion that increased investment in preventing,
    treating, and/or curing chronic diseases of the aging, such as
    Alzheimer's disease, is perhaps the single most effective
    strategy in reducing national spending on health care. Chronic
    diseases associated with aging account for more than 75 percent
    of Medicare and other Federal health expenditures.
    Unprecedented increases in these diseases as the population
    ages are one reason why the Congressional Budget Office
    projects that total spending on health care will rise to 25
    percent of the U.S. GDP by 2025.
        Simply put, our Nation does not have the luxury of time to
    wait to address the health research needs of this population.
    Standard & Poors' recent report titled ``Global Aging 2010: An
    Irreversible Truth,'' stated that no other force, no other
    force is likely to shape the future of national economic
    health, public finances, and/or policymaking at the
    irreversible rate at which the world's population is aging.
    Standard & Poors believes that the cost of caring for people
    will profoundly affect growth prospects and dominate public
    finance policy debates worldwide.
        As we have learned from the experience that we have all had
    with polio, heart disease, HIV/AIDS, cardiovascular, and other
    diseases, medical research and breakthroughs can have a
    profound impact on reducing health care costs.
        As the extension of life expectancy from age 47 in 1900 to
    almost 80 in 2000 demonstrates, medical advances enormously
    increase national productivity and prosperity. Yet those
    benefits can only come about if NIH makes the needed
    investments and research aimed at preventing, treating, or
    curing age-related diseases and extending healthy life.
        AFA, again, recognizes the serious fiscal challenges facing
    our Nation, which will require Congress to carefully scrutinize
    future funding priorities. We believe it is critical to
    leverage critical resources within the private sector,
    including not-for-profit organizations such as our own, to
    support proven, cost effective initiatives, and that is why we
    will all need Congress to be our partner.
        This subcommittee and the full Energy and Commerce
    Committee have played a critical role in overseeing and
    supporting the mission of the NIH, and we respectfully urge
    your support for continued commitment to NIA's important
    research. AFA is seeking $1.4 billion, an increase of $300
    million in fiscal year 2012 National Institute on Health budget
    specifically for the National Institute of Aging. This funding
    is the minimum essential to sustain the research needed to make
    progress in attacking the chronic diseases that are driving
    mass increases in our national health care costs. That level of
    funding would make the NIA's baseline consistent with
    comparable research initiatives conducted elsewhere under the
    auspices of NIH.
        If NIA funding is not significantly increased, we stand to
    lose a generation of more young and emerging investigators in
    aging and Alzheimer's disease. This would be an enormous waste,
    since the NIA is poised to accelerate the scientific
    discoveries that can be translated quickly into effective
    prevention and efficient health care to reduce the burden of
    this silver tsunami of age-associated chronic diseases.
        Breakthroughs from NIA research can lead to treatments and
    public health interventions that can delay the onset or slow
    the progression of costly connections such as heart disease,
    stroke, diabetes, bone fractures, age-related blindness,
    Parkinson's, and indeed Alzheimer's disease. From a budgetary
    perspective alone, such advances could save trillions of
    dollars by the middle of this current century.
        At the Alzheimer's Foundation of America, our incredible
    strength and our quick success has come from collaboration. AFA
    looks forward to working with members of the subcommittee to
    address the important issues raised in today's hearing and, in
    the long term, to end the devastation caused by Alzheimer's
    disease.
        Mr. Pallone. Thank you. Thank you, Mr. Hall.
        [The prepared statement of Mr. Hall follows:]

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        Mr. Pallone. Dr. Cantillon.

                    STATEMENT OF MARC CANTILLON, MD

        Dr. Cantillon. Mr. Chairman, members and staff, thank you
    for the opportunity to present testimony on this very important
    topic. I am Dr. Marc Cantillon, the executive director of the
    Coalition Against Major Disease of the Critical Path Institute,
    also known as C-Path.
        I am a practicing physician and a neuroscientist, with 15
    years' experience in research and drug development at the NIH,
    academia, nursing homes, and within the pharmaceutical
    industry.
        C-Path is a nonprofit organization founded in 2005 by the
    FDA and the Arizona community in order to build collaborations
    that identify more reliable and efficient methods to test new
    medicines' applied regulatory science.
        As you have heard, in spite of the exciting laboratory
    discoveries in Alzheimer's research, we lack full translation,
    we lack new medicines that could significantly alter the course
    of the disease. And, indeed, we have seen huge Alzheimer's
    disease drug trials fail. Nevertheless, there is reason for
    renewed hope.
        Across the hall into science is a proverb written up that I
    would like to quote. ``Where there is no vision, the people
    perish.'' Proverbs.
        Thanks to the work of this subcommittee, the FDA Amendments
    Act of 2007 included a provision for the FDA to create the
    Critical Path public-private partnerships. We are extremely
    grateful to Congresswoman Marsha Blackburn of Tennessee,
    Congressman Elliot Engel of New York, and Congresswoman
    Gabrielle Giffords of Arizona for their leadership on this
    legislation.
        The Coalition Against Major Diseases, or CAMD, was one of
    the first of these partnerships launched by the FDA, and it is
    already creating and identifying new tools that will speed the
    safe development of new medicines for Alzheimer's and other
    neurodegenerative diseases.
        CAMD seeks to recreate the sense of urgency and open
    collaboration that made the unprecedented rapid progress
    against AIDS possible. Sharing of knowledge was the hallmark
    and is generally accepted as the reason that the rapid and
    enduring success was secured against that epidemic. Created by
    C-Path and the Engelberg Center of the Brookings Institute,
    CAMD is a consortium that currently includes scientists from 12
    major pharmaceutical companies, NIH scientists, as well as
    experts from patient organizations such as my colleagues here
    today, the Alzheimer's Association and Alzheimer's Foundation.
        The FDA, along with the European Medicines Agency, the EMA,
    and indeed the Japanese PMDA, provide advisers to our over 250
    scientists who participate in CAMD by sharing what they know
    about Alzheimer's disease and how they can better test new
    therapies.
        CAMD's accomplishments have already changed the way we
    attack this devastating disease. Firstly, CAMD researchers
    compare the way that they and other researchers score dementia,
    scored dementia in a clinical trial, and subsequently corrected
    over a dozen inconsistencies. Now it is possible for them and
    for EMA and FDA to compare results directly from study to
    study.
        This is a great example of applied regulatory science
    because it improves the quality, the accuracy, and efficiency
    of decisions made by both the regulators and the regulated
    industry of the pharmaceutical industry.
        A first ever, CAMD was able to pool the data from 11
    clinical trials conducted by several different pharmaceutical
    companies. This has created the largest publicly available
    Alzheimer's disease database in the world, and it describes the
    natural course of the disease in over 4,000 patients. Over 200
    teams of scientists around the world are already using this.
        For example, modeling. In the past, former scientists had
    to design trials based on their clinical experience or data
    within the company or what they read in the medical literature.
    This database allows the individual patient-level data to show
    progression over time in this number of patients. This is far
    more precise than their clinical experience or what they can
    glean from the medical literature.
        This database also allows them to more accurately predict
    the outcome for a particular trial, or how long the trial must
    be, or how many patients must be included; indeed, how genetic
    subsets of the population might respond differently, et cetera.
    CAMD is now working with NIH and with academic centers to pool
    their data in the same standardized database to further enrich
    this as a leading-edge tool.
        CAMD is also helping define the FDA's new qualification
    process described in the new guidance. In this work, CAMD
    submits data and requests that the FDA accept certain brain-
    imaging tools or cerebral spinal fluid tests as qualified for
    identifying patients much earlier in their disease when there
    is still brain function to be saved.
        Yes, there are many reasons for hope. The Critical Path
    public-private partnership is improving the applied regulatory
    science for Alzheimer's at the FDA. However, we do need your
    help. Understaffing is a serious problem throughout the FDA and
    is especially serious for CAMD. The FDA needs your support to
    be able to dedicate the required number of scientists and staff
    to participate in CAMD and other Critical Path partnerships.
    This is the kind of applied critical science that is changing
    the way drugs are tested and evaluated today, so that
    Alzheimer's can be prevented, not just slowed.
        I thank you for the opportunity to provide this testimony,
    and everybody in the CAMD thanks you for your leadership and
    foresight in authorizing the FDA's Critical Path public-private
    partnerships that are giving new hopes to patients and families
    at risk for this devastating disease. I would be happy to
    answer any questions.
        [The prepared statement of Dr. Cantillon follows:]

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        Mr. Pallone. Thank you, Doctor.
        I thank all of you. We will take questions from the
    members, and I will start with myself, and I will start with
    Dr. Morrison-Bogorad.
        Scientists know Alzheimer's attacks the brain long before
    people exhibit cognitive decline. But the specifics are crucial
    because, so far, drug after drug has failed to effectively
    treat Alzheimer's in people who already show symptoms. I know
    you suggested that that was part of the problem, that perhaps
    the answer is earlier treatment before you actually have the
    signs of the disorder. So what I wanted to ask is why are
    biological markers, whether gene mutations or pathological
    brain changes, important to the development of effective
    treatments for Alzheimer's and what research is NIA conducting
    to better understand these markers? I am sort of going back to
    that same issue that you mention, is perhaps we should be
    starting earlier but then we would have to know if people have
    the disorder.
        Ms. Morrison-Bogorad. It is probably one of the items that
    we are pushing most of our effort into these days, because we
    do think that understanding the earlier stages of Alzheimer's
    disease is very important and we have thought that ever since
    we reissued the request for applications for funding our
    Alzheimer's disease centers across the country. Because about 8
    years ago now we said to them, forget about late stages of
    disease. We want you to really, really concentrate on the
    earlier stages.
        So we have thought about this for quite a long time; and,
    obviously, one of the things that held us up is not being able
    to identify preclinical stages. That is one of the things that
    is really being addressed by the Alzheimer's disease in your
    imaging initiative, especially in people who aren't yet showing
    symptoms or in people who are developing mild cognitive
    impairment, which is a precursor to Alzheimer's. Researchers
    working together with industry and people funded by us are
    identifying markers in the cerebrospinal fluid, and these
    markers are lowered beta-amyloid and higher levels of protein
    called tau that signal that a person is approaching the stage
    of mild cognitive impairment.
        The other technology which has been developed by ADNI and
    by others is actually being able to look at in the brains of
    individuals cerebral amyloid plaques through positron emission
    tomography, through imaging. And this is perhaps the most
    amazing breakthrough over the last several years because that
    has allowed us to see that in a number of folk, older folk,
    older than 65 or 70, about 20 percent of these folk who
    otherwise would have been thought of as normal, who are quite
    normal cognitively, have levels of amyloid plaques in their
    brain that in some cases are equivalent to a person with
    Alzheimer's disease who can't at the moment function for
    themselves.
        So the CSF markers and the brain markers are two ways we
    have of identifying preclinical disease which we didn't have
    before, and they could be used to identify people who have got
    markers in the brain, amyloid in the brain for earlier clinical
    trials than we are able to do right now. So I agree. It is
    really, really, really important that we develop these markers
    and that we use them to do more efficient clinical trials in
    the preclinical stage.
        Mr. Pallone. I had a second question, but I maybe would
    prefer if anybody else would want to comment on this issue
    because I think it is pretty important. Would any of the others
    like to----
        Mr. Johns. I simply add that what Marcelle has said is
    certainly one of the most exciting areas that is occurring in
    Alzheimer's research today. She has indicated that we have
    worked together on this at the Alzheimer's Association
    International Conference on Alzheimer's Disease over the
    summer. There were significant findings released on this very
    front. It is potential to go to the point where we can actually
    identify Alzheimer's presymptomatically in the future. It is
    not ready for the clinic. That is for the lab at this point.
    That is a significant set of advances that are very important
    to us.
        What is of course very important is that we have a parallel
    in treatments. Right now, we are making faster advances on the
    diagnostic science than we are on treatment side. So what we
    really need to do is catch that up. And that is one of the most
    important reasons for the additional funding that is really
    needed for Alzheimer's disease.
        Mr. Pallone. Thank you.
        Mr. Gingrey.
        Mr. Gingrey. Mr. Chairman, thank you.
        I think I will shift then to the treatment aspect of it and
    maybe come back to very interesting things that the two of you
    have just talked about with regard to early diagnosis.
        Dr. Cantillon--I hope I did better. I know I botched that
    up pretty bad the first time--I have a lot of respect that the
    FDA, the Food and Drug Administration, performs. With that
    being said, I am interested in exploring how the FDA drug
    approval process might be improved in the hope it may help spur
    a greater drug development for diseases such as Alzheimer's.
        I think I mentioned in my opening remarks that I have
    introduced legislation along with my colleagues here on the
    committee, Energy and Commerce Committee, Health Subcommittee,
    bipartisan, Mr. Green and Ms. DeGette on the Democratic side
    and myself and Mr. Rogers from Michigan on this side, the GAIN
    Act. This is in regard to the shortage of antibiotics. So a
    different disease, a different category of drugs, but equally
    as important. Can you tell me, Dr. Cantillon, how applying
    scientific advances such as the use of biomarkers or drug
    development tools might aid in drug development in this
    country?
        Dr. Cantillon. Yes. Thank you for that question.
        So, actually, as a medical director of Alzheimer's and
    other programs with Schering Plough over the last couple of
    years before CAMD, I did sit on an industry advisory group for
    this ADNI trial that Dr. Bogorad was speaking about. So I was
    giving some advice into the choice of the instruments and that
    these markers were being developed, had my hat on in terms of
    both drug development and facing the FDA with a package for an
    approval for a treatment.
        The trouble is when you are coming from a drug developer's
    point of view, this is all very cutting edge. And as I said in
    my testimony, the science by itself is truly not enough. It is
    not enough to have exciting markers that may predict something
    that is going on in the brain if it can't be harnessed into a
    path and the development steps to use a new drug and prove
    that. I will give you an example.
        So we talked just now about the cerebrospinal fluid. We
    know there are certain proteins that can indicate both the
    disease and perhaps even the type of progression predictive. We
    would take that and we are taking that and in a collaborative
    way with the whole field. So we are just one collaboration that
    I had mentioned. Look at the evidence for that in a critical
    way, in a scientific manner.
        The regulatory science part is having our regulatory
    scientific colleagues internationally review that in a context
    of use. Does that allow you to choose a population for a trial
    who are not yet demented? So to call somebody demented, you
    don't need to be a doctor. It is very clear that the person
    does not have their brain functions in the same way for memory
    and so forth. To find somebody that is very early in the
    disease or even hasn't fully shown clinical symptoms, you need
    these markers.
        Can we ask for FDA regulatory approval that these are
    standardized in such a way that they can become a tool, a
    standard tool publicly available to any company in this country
    or anywhere else? Can take off the shelf and put into a program
    such that, by using this tool, they don't have to defend that
    tool when they go in front of the FDA? That process has already
    been done in this qualification. And instead they can focus on
    their own particular drug that then fits into this pattern and
    can use that patient population, for example, to show
    progression over time. Do those people who have low tau, high
    tau, low a-beta or a particular brain picture with amyloid, do
    they progress faster than others and can you show a difference
    in the people who were on drug and off drug? That is how the
    whole development process can make use of this science and
    translate it into something that the FDA can then approve or
    not approve.
        The FDA did put out a guidance document partially from
    working with us just 2 months ago, and in that the steps are
    laid out very clearly. Essentially, it is show us the evidence.
    Very similar----
        Mr. Gingrey. My time is rapidly drawing to a close, but let
    me quickly ask you, do you think it is important that such drug
    development tools--biomarkers--that they first receive approval
    by the FDA before being used by industry and the agency to
    measure the safety and efficacy of the drug? Do you think that
    the FDA would have to approve this off-the-shelf kind of
    testing ahead of time?
        Dr. Cantillon. The FDA has the possibility just to approve
    for commercial use or other use, but that is not within the
    context of use that we are talking about. The context of use
    would help that tool help define a particular population. So,
    for example, let me give you another--for another consortium.
    We developed some markers for renal injury, for kidney injury.
    They were brand new, and they could allow a drug developer or
    anybody to show if something was happening very early on before
    the kidney actually was destroyed. These markers went through
    this qualification process and are being very widely used by
    all companies, including my former one, to make decisions about
    drug development. When they go to the FDA, they don't need to
    defend those markers for kidney. They have already been
    approved. So it takes a lot of that work away and you can focus
    on the drug.
        Mr. Gingrey. Doctor, thank you. That does answer my
    question. And I will yield back, Mr. Chairman.
        Mr. Pallone. Thank you.
        The gentlewoman from the Virgin Islands.
        Mrs. Christensen. Thank you. Thank you, Mr. Chairman.
        Dr. Morrison-Bogorad, given the disproportionate impact of
    Alzheimer's on minorities, is the National Institute of
    Minority Health and Health Authority Research, which was
    formally the center among the NIH institutions that you are
    collaborating with? And, also, how diverse are the participants
    in the clinical trials?
        Ms. Morrison-Bogorad. It is again something that we paid
    particular attention to, especially in our flagship clinical
    trials, the Alzheimer's disease clinical consortium, and there
    we have made a rule that a certain number of people in each
    clinical trial that we run there are minorities. And that has
    been extraordinarily helpful because it has meant that I think
    a fifth of the folk who participate in certain of these studies
    are minorities. So it is amazing what a little rule will do.
        And we certainly have got quite a vibrant program in
    epidemiology looking at Alzheimer's disease in minorities and
    comparing that with Alzheimer's disease. And I would say at the
    moment the results are somewhat equivocal because many of the
    ways in which you define Alzheimer's disease are also very
    dependent on things like the education of the person who is
    taking the tests. And many older African Americans, of course,
    for other reasons haven't had the education that they should
    have had and so they don't do as well on these tests as they
    should. It doesn't mean they have Alzheimer's, however.
        So this is a very, very thorny issue and we have gotten a
    number of very good researchers working on that to actually try
    and tease out what part of the minority burden of Alzheimer's
    disease is real--and I do believe some of it is because some of
    the possible things that cause Alzheimer's disease are, as you
    are aware, much more prevalent in minority communities, things
    like heart disease. But I do believe that some of the numbers
    are a little bit over, perhaps larger than they should be
    because of this issue on how to determine Alzheimer's disease
    in people with different backgrounds.
        Mrs. Christensen. That is interesting, because my
    impression is that it is underdiagnosed rather than
    overdiagnosed in minorities. And I will let anybody comment on
    that.
        But I wanted to ask Mr. Johns, if I can get this question
    straight, because I know this hearing is really about getting
    funding for Alzheimer's. And, Mr. Johns, I heard your argument
    very clearly about the need for an increased investment in
    Alzheimer's to reduce the cost of health care eventually and to
    perhaps even save Medicare. We have been trying to get CBO to
    score prevention for a while, actually introduced legislation
    to have them do that when they are asked by the committee. So,
    without having scoring in place for prevention, how do you
    foresee getting the funding needed, especially in a Congress
    that is committed to cutting spending? And how important do you
    think scoring prevention is to this particular issue?
        Mr. Johns. Well, certainly, as you say, the fact is that
    CBO won't score what I would describe as a game changer. That
    is a problem I know for all of us when we have interest in what
    would be effectively R&D for our country. We really have--
    beyond the immediacy of Alzheimer's, we have what is a
    potential brain drain in our country as a result of research
    being attracted overseas. While it isn't specific to
    Alzheimer's, it is generic and related to Alzheimer's, as well
    as other medical research.
        So we have as a country to face what is, first of all, a
    significant problem in that larger regard with medical research
    but very specific in Alzheimer's; and, of course, we have the
    challenge of facing our economic realities and also then
    funding something that cannot be scored. We recognize fully the
    difficulties of this, but we can also see from the projections
    we have done--and we have gone to outside sources at the
    Alzheimer's Association to develop what are these data. We have
    actually used the CMS data on expenditures on Medicare and
    Medicaid. We have taken those to Dartmouth. We have had the
    Lewin Group look at all these data and what we have identified
    is that $20 trillion cost over the next 40 years.
        One of the problems we have as a country, of course, is
    actually addressing problems that are longitudinal. Those of
    you sitting across from me know that better than I in terms of
    how hard it is to make those things work. But we certainly know
    it, too, the Alzheimer's Association and any of us here sitting
    on this side who are trying to change the course of Alzheimer's
    disease. We have to find the national fortitude to address this
    already enormous problem. Everyone who has the disease today
    will die with it or of it. We do not have a treatment that
    stops or even slows it. The devastation of the disease at a
    human level for all of us who have experienced it personally
    and for all of those who haven't, we recognize just how bad
    that is.
        I don't have the easy answer to your question, but the
    scale of the problem, the enormity of the issue begs for us to
    find a way to answer the question so that we can address this
    now. We are running out of time.
        One of the things that Marcelle mentioned is that the
    science community believes ever more that we need to intervene
    sooner, that the plaques entangles of the disease are deposited
    earlier in life, at least 10 years before the symptoms
    manifest. If, in fact, we don't make these investments
    relatively soon, the baby boomers, 10 million of whom will have
    this disease, will be a lost cause. And the devastation at a
    human level and the economic toll will be solidified if we
    don't move relatively soon.
        Mrs. Christensen. Thank you. Thanks.
        Mr. Pallone. I thank the gentlewoman.
        Next, we have our Alzheimer's hero here, who actually
    sponsored both of the bills that you mentioned, Mr. Johns, the
    one that I guess is now in the House for action hopefully next
    week, as well as the larger bill. Mr. Markey.
        Mr. Markey. Thank you, Mr. Chairman, very much; and I thank
    our witnesses so much for your participation here today.
        Robert Browning wrote, grow old with me, the best is yet to
    be. But the truth is that for millions of millions of Americans
    the golden years are now the worst years because of Alzheimer's
    and the family caregiver who has to help. So this is now at 4
    million or 5 million Americans already an epidemic since, as we
    know, not only does the Alzheimer's patient have the disease,
    but one family member has it as well as. So about 10 million
    Americans right now are living with it on a daily basis in
    their homes or in some facility. And when it goes up to 12
    million times 2, 24 million, 25 million people, the caregiver
    and the patient, it is going to be an incredible moment in
    American history. So we have an incredible responsibility here
    to make sure that we put in place a plan.
        And, Mr. Chairman, you made reference to it, which is that
    the National Alzheimer's Project Act, which I introduced on
    this side along with Christopher Smith, the co-chair of the
    Alzheimer's Task Force, passed the Senate last night. And
    Senator Bayh and Senator Collins did an excellent job in
    framing it up and we will be able to pass that next week on the
    House floor. And then we will have a plan. We will have
    something that makes it possible for us to put in place
    something that is the plan to attack this disease. And it is
    long overdue, but it is a good beginning.
        So let me ask you this, and maybe you could reflect upon
    it, Mr. Johns, if you could. Last year, the Federal Government
    spent $122 billion on helping people with Alzheimer's, but we
    only invested $469 million in finding the cure, and we know we
    are only at the beginning of an explosion of the bills that are
    going to come in across America for the Federal Government to
    help families with Alzheimer's. Can you reflect upon that, give
    us your insight as to how big it is going to become and why it
    is imperative that we act now?
        Mr. Johns. Certainly. And let me thank you, Mr. Markey, for
    your authorship of NAPA and the input and leadership of yours
    and the committee's in moving that forward.
        Certainly Alzheimer's is already costing $172 billion in
    total, the $122 billion you talked about from the Federal
    Government. Incidentally, at the Medicare level, Alzheimer's is
    driving 17 percent of the Medicare budget----
        Mr. Markey. Say that again.
        Mr. Johns. Seventeen percent of the Medicare budget is
    driven by Alzheimer's today. The total cost for Alzheimer's
    again to the country and other dementia is, by the middle of
    the century, in excess of $1 trillion per year; and by far the
    bulk of that will be the Federal Government's cost projected
    from today's levels with no changes. So that it simply won't be
    affordable not only on the economic front but again on the
    human front.
        We can't accept what will happen to families. We don't have
    the ability to deal with the end-of-life considerations of the
    long-term care. Families at some point, dedicated as they are,
    with 70 percent of the people who have Alzheimer's living at
    home and cared for at home, at some point that other percentage
    as a result of the fact that families, no matter how much time
    they spend, the 24 hours a day that they often spend as
    caregivers, especially toward the end of life, is no longer
    enough or they are simply not capable of handling the
    difficulty of the care at home so that we are not equipped at
    this point. As you indicated, we don't have a plan for any of
    these things at this point. NAPA will hopefully address that,
    but we are just not prepared as a country to handle any of
    these problems at the scale they are going to rise to.
        Mr. Markey. This is just something that is not as well
    understood as it should be. My mother had Alzheimer's, and she
    was a valedictorian. My father was a milkman. And my father
    always said it was an honor that my mother married him. And he
    used to say, as well, if the strength of your brain determined
    who got Alzheimer's that he would have had it and my mother
    would have been taking care of him. But we know that this is an
    equal opportunity disease. At age 80, 82, 84, 86, 88, my father
    kept her in our living room with the arms of a milkman, arms
    the size of my legs; and he was able to do it.
        But for many families it becomes exhausting. You can't do
    it. There is a point beyond which you need help and that helps
    comes increasingly from the Federal Government in the form of
    $122 billion a year right now.
        But I don't think actually we are going to be able to solve
    the Federal budget deficit if we don't dramatically increase
    the Federal investment in research. It will be a trillion
    dollars a year just for Alzheimer's care in another 15 years,
    and it is just a number that is going to increase
    exponentially. And despite the efforts of people like my father
    and other families all across the country, these people are
    heroes, but heroes need help and they need hope. And only the
    National Institutes of Health, really the institutes of hope,
    really give people the courage to keep on going.
        So this whole effort is absolutely--I think it should be
    the number one issue, to be honest with you, just from a
    budgetary perspective. From a humane perspective, yes. Coupled
    with the Alzheimer's Breakthrough Act, which I have introduced,
    and the HOPE Act, the Health Outcomes, Planning and Education
    Act, which we have to focus on, we have to put in place the
    kind of ingredients of this plan that make it possible for us
    to solve this problem. And I commit to you, all of you, that I
    am going to continue to just work my heart out to make this
    something that becomes real in people's lives; and I cannot
    thank you enough all of you for your support.
        And, Mr. Chairman, I thank you for conducting this hearing.
    I don't think there is a more important subject for us to be
    discussing as Americans.
        Mr. Pallone. Thank you. And thank you for all you do, Mr.
    Markey, on this and other issues.
        Mr. Engel.
        Mr. Engel. Thank you. Thank you very much, Mr. Chairman.
    Right in the nick of time.
        First of all, I want to thank everyone on the panel. This
    is certainly a very, very important and--and something I have
    had a lot of concern about. I think that--what all my
    colleagues have said--this is what we ought to be spending
    money on when we talk about some of the other issues. I think
    we should all agree on issues like this.
        Mr. Chairman, I want to ask unanimous consent to insert my
    opening statement in the record.
        [The information was unavailable at the time of printing.]
        Mr. Engel. Let me ask Dr. Cantillon--first of all, thank
    you for your comments. I was told the comments you made before,
    and I deeply appreciate your saying that. The Critical Path
    Initiative is certainly something that is near and dear to my
    heart. I have strongly supported public-private partnerships,
    and I am pleased to learn that this program has been very
    effective in tackling diseases like Alzheimer's.
        You mentioned in your testimony, Doctor, that one way
    Congress can be helpful is to provide the resources to
    increasing staffing levels at FDA; and, as I mentioned before,
    I couldn't agree more. We need to increase resources for the
    FDA to help them bring drugs to market. But, given the limited
    resources we are working with, I was wondering if you could
    address other ways that we might help break down the barriers
    to translational research and help fill in the gap that has
    opened up between biomedical researchers and the patients who
    need their discoveries, which we unfortunately referred to as
    the valley of death.
        Dr. Cantillon. Indeed, thank you and thank you for your
    support for these partnerships.
        I think that the partnership, the public-private
    partnerships, are certainly a major part of the answer in this
    fiscal environment. So we have all said several times that this
    is about to bankrupt our country and many other aging countries
    around the world and there aren't unlimited funds either to put
    into any one particular disease. And maybe we need to look at
    an innovative science and an innovative way of answering some
    of these questions that have come up.
        So the FDA is going to be faced with a lot of the new
    science arriving in different ways. Part of what we have been
    working together with them was to put a process in place to
    translate this science, not just, let us say, from the test
    tube to the rat, but all the way through to a new medication at
    the very end. In other words, to make a process available to be
    able to gather the evidentiary information.
        The FDA doesn't have but a few handful of staff that we
    deal with on a very regular basis and, as I mentioned, are
    indeed a part of our consortium; and the Europeans, in fact,
    are in a similar situation. So what I was referring to is
    basically stretching the dollar and the people that we have.
    Part of what we are doing and seek to do more of is in fact
    build an in-kind work, and there is a lot you can do with that.
    There is a lot of scientists, just like there was a lot of
    data, who have been siloed, be it within government--I used to
    be at NIH--or within companies.
        Once a trial has failed, that data is essentially put on
    the shelf somewhere. Definitely with the kind of tools we are
    talking about, those data can be re-examined, at the very
    least, and perhaps there will be some pearls in there. But they
    also can be mined for the learnings that are there and shared.
    That is public and belongs to all of us.
        So what we put together are these various methods to do
    that. It is, I would say, an innovative tool to get people to
    give up their silo thinking, look at a precompetitive space for
    companies and even for academics, that they actually don't own
    the data that they have generated, that it belongs to the
    people. And if we can set it up that way, have it as a
    database, for example, as I mentioned, but also the other
    tools, then that is freed for the best minds in the world to
    attack and that is actually a very efficient way of doing that.
        Mr. Engel. Thank you for pointing that out. It certainly is
    a shame if research is put on the shelf and no one else can get
    to it or look at it. This has to be a collaborative effort,
    obviously, and thank you for pointing that out.
        I would like to ask a question of Mr. Hall and Mr. Johns.
    As I am sure you are aware, the Patient Protection and
    Affordable Care Act, which is referred to as health care
    reform, that we just passed here, we were doing this for as you
    know almost 2 years. There was a provision in there that
    improves access to home and community based care for patients.
    We know that these services greatly improve the quality of life
    for Alzheimer's patients.
        Health care reform, as we know, strengthens the long-term
    care system for chronic and other long-term neurological
    conditions both by eliminating the arbitrary caps on treatment,
    which we did--that was one of the crowning glories of this
    bill--and by expanding coverage to include preexisting
    conditions, which is the second pillar that is so important in
    this bill.
        In an effort to improve upon existing programs that
    positively impact Alzheimer's patients and help you provide
    services, can you give us some insight as to how these
    provisions will improve your ability to provide services for
    Alzheimer's patients and their families? And can you also
    address what other Federal programs exist to help you deliver
    services to more patients?
        Mr. Johns. Well, I personally think that all of our
    constituents are in a position, especially, as I mentioned
    previously, that 70 percent or more of people are cared for at
    home. All of our constituents who are in a position to be at
    home need additional assistance. As we see how all this
    unfolds, we will learn better exactly how it can best serve the
    individuals who are in those situations. So we certainly always
    have high hopes for what would help to be a better care at
    home.
        Because we know, as I mentioned a little bit earlier, that
    we do not have the capability to really accommodate all the
    folks who would ultimately perhaps need to go to long-term
    care. So additional ways to find ability to handle people at
    home is critical to the entirety of the Alzheimer's
    constituency.
        Mr. Hall. Additionally, I think we all agree that the
    longer we can prolong institutionalization the better it is for
    the Federal budget, for sure. But families do need an enormous
    amount of support. The conversation we have had here around
    research is pivotal. There is no doubt we need to find a cure
    as quickly as possible, and any amount of money that we can put
    towards this disease would be an enormous win at this point.
    But the reality is that a cure does not seem to be coming
    anytime soon, and so it does rely on care, and it does rely on
    those families. So any type of provision that supports
    individuals with the disease and cares for them and provides
    for them the greatest quality of life for the longest period of
    time is great.
        But also, too, we are recognizing the support that is truly
    needed for caregivers across the country at this point, at this
    juncture where we are in relationship to a cure is really the
    critical step. It is what we need to do.
        Mr. Engel. Thank you. Thank you, Mr. Chairman.
        Mr. Gingrey. Mr. Chairman, just very quickly--and I know
    the afternoon is getting long, and I appreciate our witnesses
    who have done a wonderful job. I guess I would direct this to
    Mr. Hall. Can you talk about the benefits of early detection as
    it relates to both the financial realities that patients face
    and for making end-of-life decisions?
        Mr. Hall. Sure. The Alzheimer's Foundation of America hosts
    and is the initiator of National Memory Screening Day, and the
    reason that we do that is really just to sort of educate the
    public as a whole and then to allow individuals to participate
    in memory screenings across the country. That isn't a diagnosis
    for Alzheimer's, but rather is looking to see if there is an
    indication of I guess the most common manifestation of
    Alzheimer's disease, which is memory problems. That initiative
    to us is really important because of the fact that it points to
    a possible early diagnosis of this disease. It is really
    critical because our experience at the Alzheimer's Foundation
    of America is that our phone calls, our e-mails in the volume
    that we receive, every single one of those families is in
    crisis and chaos. So they are really scrambling now to figure
    out what does Alzheimer'sdisease care look like? What am I now
    responsible for as a family? What is required of me legally,
    financially? What is required of my time?
        Early diagnosis in our interpretation is really important
    because, one, I think some of the treatments that are available
    right now are able too offset the progression of the symptoms
    of the disease and therefore the person enjoys--the person with
    the disease enjoys a higher quality of life for a longer period
    of time.
        And I have to tell you, traveling the country--and I am
    sure Harry could say the same thing--We have not met one single
    family anywhere that hasn't said that all they wanted was one
    more good day with their loved one who is in the grips of
    Alzheimer's disease. If we can prolong one more day, I think
    that is a win. That is what we have right now.
        But, additionally, planning in this situation is enormous,
    educating, empowering the family unit so that they understand.
    It is generally one in four individuals caring for every person
    with Alzheimer's disease. But also then enabling organizations
    to surround those families, to hold their hands, to walk with
    them on the journey and support them, to connect those families
    at the point of diagnosis with those necessary resources,
    instilling hope, which is probably the greatest missing link in
    Alzheimer's disease.
        At least by surrounding a family with hope you are doing
    just that. You are giving them a lifeline, and you are letting
    them know that they are not going to be alone in the process.
    That takes care of an enormous emotional toil for a family,
    which is probably the biggest piece of the picture.
        And then if you are able to bring in other resources of
    financial planning and legal planning and what all this looks
    like as far as care in the future, those are enormous wins in
    alleviating the burden, the stress, depression for caregivers.
        Mr. Gingrey. Thank you.
        Mr. Pallone. Thank you. That concludes our questions, but I
    just want to thank you all of you. It is obvious from listening
    to the questions and your testimony how important this is both
    now and in the future. We do plan to move the one bill that
    passed the Senate on the House floor next week; and, of course,
    the larger bill will have to wait for another time. But this
    is--I just want to stress how important really and how we
    really plan to prioritize this. So thanks a lot.
        Let me mention that you may get additional questions from
    the members to answer in writing. The members are supposed to
    submit those within the next 10 days or so, but you may get
    those and the clerk will notify you of that.
        But, without objection, this meeting of the subcommittee is
    adjourned.
        [Whereupon, at 3:21 p.m., the subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]

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